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Atrasentan in Patients With Proteinuric Glomerular Diseases (AFFINITY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04573920
Recruitment Status : Active, not recruiting
First Posted : October 5, 2020
Last Update Posted : May 3, 2024
Sponsor:
Information provided by (Responsible Party):
Chinook Therapeutics, Inc. ( Chinook Therapeutics U.S., Inc. )

Study Description
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Brief Summary:
The AFFINITY Study is a phase 2, open-label, basket study to evaluate the efficacy and safety of atrasentan in patients with proteinuric glomerular disease who are at risk of progressive loss of renal function.

Condition or disease Intervention/treatment Phase
IgA Nephropathy Focal Segmental Glomerulosclerosis Alport Syndrome Diabetic Kidney Disease Diabetic Nephropathy Type 2 Immunoglobulin A Nephropathy Drug: Atrasentan Phase 2

Detailed Description:

The AFFINITY Study is a phase 2, open-label, basket study to evaluate the efficacy and safety of atrasentan in patients with proteinuric glomerular disease who are at risk of progressive loss of renal function. Cohorts will consist of patients with:

  • IgA nephropathy (IgAN) with urine protein:creatinine ratio (UPCR) of 0.5 to less than 1.0 g/g
  • Focal segmental glomerulosclerosis (FSGS)
  • Alport syndrome
  • Diabetic kidney disease (DKD) on top of background care of a RAS inhibitor and SGLT2 inhibitor

Additional cohorts may be added as data is available.

Approximately 100 patients will be enrolled in the study. Approximately 20 patients will be enrolled in each cohort to receive 0.75 mg atrasentan QD for 52 weeks. The study will also evaluate efficacy and safety of 1.5 mg atrasentan QD in FSGS subjects who received 0.75 mg atrasentan and it was well tolerated.

Patients will be allowed to continue into treatment extension and receive oral atrasentan QD for up to an additional 84 weeks (total maximum treatment of 188 weeks),

The primary objective of the study is to evaluate the effect of atrasentan on proteinuria (for IgAN, FSGS, and Alport syndrome patients) or albuminuria (for DKD patients) levels. Exploratory objectives include evaluating the change in kidney function over time as measured by eGFR, safety and tolerability. To facilitate study participation over this time period, where allowed by local regulations, options for remote study visits using telemedicine and home health may be offered.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Open-Label, Basket Study of Atrasentan in Patients With Proteinuric Glomerular Diseases
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : July 31, 2024
Estimated Study Completion Date : August 1, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Atrasentan 0.75 mg
Once daily oral administration of 0.75 mg atrasentan
 Drug: Atrasentan
Film-coated tablet
Other Names:
  • CHK-01
  • Atrasentan Hydrochloride
  • ABT-627
Experimental: Atrasentan 1.5 mg
Once daily oral administration 1.5 mg atrasentan (FSGS cohorts only)
 Drug: Atrasentan
Film-coated tablet
Other Names:
  • CHK-01
  • Atrasentan Hydrochloride
  • ABT-627


Outcome Measures
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Primary Outcome Measures :
  1. Change in proteinuria for IgAN, FSGS, and Alport syndrome patients receiving 0.75 mg atrasentan QD [ Time Frame: Up to Week 12 or approximately 3 months ]
    The change in urine protein:creatinine ratio (UPCR) from baseline to Week 12

  2. Change in albuminuria for DKD patients [ Time Frame: Up to Week 12 or approximately 3 months ]
    The change in urine albumin:creatinine ratio (UACR) from baseline to Week 12

  3. Change in proteinuria for FSGS patients at 1.5 mg dose [ Time Frame: Up to Week 24 or approximately 6 months ]
    The change in urine protein:creatinine ratio (UPCR) from baseline to Week 24

  4. Change in proteinuria for FSGS patients at 1.5 mg dose [ Time Frame: Up to Week 30 or approximately 7.5 months ]
    The change in urine protein:creatinine ratio (UPCR) from baseline to Week 30


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 years and older for patients in the IgAN, FSGS, and Alport Syndrome cohorts
  • Age 18-70 years for patients in the DKD cohort
  • Receiving a maximally tolerated dose of RAS inhibitor therapy (ACEi or ARB) that has been stable for at least 12 weeks.

  • For patients enrolling in IgAN Cohort:

    1. Biopsy-proven IgA nephropathy
    2. UPCR between 0.5 to less than 1.0 g/g
    3. Screening eGFR ≥ 30 mL/min/1.73 m2

  • For patients enrolling in FSGS Cohort:

    1. Biopsy-proven FSGS or documented genetic mutation in a podocyte protein associated with FSGS
    2. UPCR > 1.0 g/g
    3. Screening eGFR ≥ 30 mL/min/1.73 m2
    4. Subjects receiving systemic corticosteroids or other immunosuppressants must be on a stable dose for at least 12 weeks.
    5. BMI ≤ 40 kg/m2

  • For patients enrolling in Alport syndrome Cohort:

    1. Diagnosis of Alport syndrome by genetic testing
    2. UPCR > 0.5 g/g
    3. Screening eGFR ≥ 30 mL/min/1.73 m2

  • For patients enrolling in DKD Cohort:

    1. Diagnosis of type 2 diabetes mellitus
    2. UACR ≥ 0.5 g/g
    3. Screening eGFR ≥ 45 mL/min/1.73 m2
    4. Receiving a stable dose of SGLT2 inhibitor for at least 12 weeks
  • Willing and able to provide informed consent and comply with all study requirements

Exclusion Criteria:

  • Current diagnosis of another cause of chronic kidney disease or another primary glomerulopathy.
  • History of kidney transplantation or other organ transplantation.
  • Except for FSGS patients, use of systemic immunosuppressant medications, such as steroids, for more than 2 weeks in the past 3 months.
  • Blood pressure above 150 mmHg systolic or 95 mmHg diastolic as evaluated by the Investigator.
  • History of heart failure or a previous hospital admission for fluid overload.
  • Clinically significant history of liver disease as assessed by the Investigator.
  • Hemoglobin below 9 g/dL as measured by the Investigator or blood transfusion for anemia within the past 3 months.
  • Clinical diagnosis of nephrotic syndrome
  • Malignancy within the past 5 years. Exception to the criteria include nonmelanoma skin cancer and curatively treated cervical carcinoma in situ.
  • For women, pregnant, breastfeeding, or intent to become pregnant during the study.
  • For men, intent to father a child or donate sperm during the study.
  • Recently received an investigational agent.
  • Clinically significant unstable or uncontrolled medical condition as assessed by the Investigator.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04573920


Locations
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Sponsors and Collaborators
Chinook Therapeutics U.S., Inc.
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Responsible Party: Chinook Therapeutics U.S., Inc.
ClinicalTrials.gov Identifier: NCT04573920    
Other Study ID Numbers: CHK01-02
First Posted: October 5, 2020    Key Record Dates
Last Update Posted: May 3, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Glomerulonephritis, IGA
Glomerulosclerosis, Focal Segmental
Nephritis, Hereditary
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
 Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases
Urogenital Abnormalities
Congenital Abnormalities
Collagen Diseases
Connective Tissue Diseases
Atrasentan
Antineoplastic Agents
Endothelin A Receptor Antagonists
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action